Pharmacy Errors and Children

Lawsuit Over 4 Year Old Girl Given Five Times Correct Dose of Medication

October 21, 2013 | Lebowitz & Mzhen

The family of a young girl recently filed a $750,000 federal lawsuit against her local pharmacy, alleging that the business wrote the incorrect directions on her prescription for a seizure medication, causing the girl to take five times the proper dosage of the drug.

According to the lawsuit, the little girl was given a prescription when she was four years old for two milliliters of an anti-seizure medication, to be taken twice a day. However, when the prescription was filled, the instructions stated that the girl should be given two teaspoonfuls twice a day. One teaspoon is the equivalent of almost five milliliters. The pharmacist in the case stated that she repeated the dosage back to the doctor at the time it was filled, and it was confirmed as written.

The young girl’s mother stated that immediately after giving her daughter the incorrect dosage, the girl suffered a serious seizure requiring immediate hospitalization and treatment at a local hospital. According to the lawsuit, the girl became catatonic, and the girl was later transferred to a Children’s Hospital where she remained unconscious for some time. Once she regained consciousness, the girl was unable to walk, and had to be fed baby food, resulting in a 17-18 pound weight loss. She reportedly still suffers side effects from the incorrect drug dosage, and is afraid of taking medicine.

Mother Sues Pharmacy over 6 Year Old Daughter’s Death in 10x Correct Dosage Case

August 22, 2013 | Lebowitz & Mzhen

A mother is reportedly suing her longtime pharmacy, claiming that a dosage error led to her daughter’s death.

The woman claims that her 6 year old daughter died after taking a dose of morphine 10 times higher than what she was prescribed. The little girl had been taking the liquid painkiller during the course of treatment for sickle cell anemia. Sadly, this tragedy comes on the heels of a report regarding similar errors in the administration of pain medications in young children.

The lawsuit alleges that the young girl died in April 2012, just one day after taking the hyper concentrated dosage. It further claims that the girl’s cause of death was officially ruled “morphine toxicity.”

Study Examines Cause of Errors in Opioid Infusion Errors in Children

August 8, 2013 | Lebowitz & Mzhen

Of all of the types of pharmacy and medication errors that are made, some of the most frightening to think about are those that occur with children.

One recent study (registration required) focused on errors made with pain medicine, specifically opioid infusions in children.

The researchers in the study analyzed patient safety and pharmacy data in search of potential critical incidents in patients receiving opioid transfusions over a five year period, from December 2004 to December 2009. Those incidents that scored at least an 8 out of 10 for seriousness were then further investigated in order to conduct an analysis regarding the cause of the error.

The researchers initially identified 166 potential incidents. Out of those, 58 incidents included one (45) or more than one (13) relevant critical incidents. According to the researchers, the most common incident was opioid administration error, which had occurred in 39 of the cases cases (67%).

Fourteen of the incidents were isolated for root cause analysis, which identified 31 root causes. The most frequent and significant ones involved defective preprinted order sheets for the opioid infusions; lack of nursing guidelines for the infusion adjustment rate and weaning off the medication; and inadequate policies and guidelines for monitoring and recording pain, vital signs and arousal. Most significantly, the errors were attributable to an issue with policies/procedures, communication errors, environmental/equipment issues, and inadequate training.

While researchers were not able to study the potential impact of fatigue because the study was retrospective, they did identify one major problem, which involved the transferring of patients between units. The errors were more likely to occur at that point in time because there was no standard set of policies and procedures, increasing the potential likelihood for error.

Pharmacist’s License Revoked Following Dangerous Drug Mistakes

June 24, 2013 | Lebowitz & Mzhen

A Rhode Island pharmacist, and former state senator, has had his license revoked from the state earlier this month (registration required), following the accidental administration of morphine to two children who received medicine from the pharmacy where he worked.

The Health Director, Michael Fine, ordered the pharmacist’s license to practice revoked, stating the seriousness of the errors, and that a third serious dispensing error of this nature could lead to the potential death of a patient. This was reportedly the second time since 1999 that a pharmacy under the man’s control had made a major labeling error.

According to the order, the man’s license was initially suspended in March 2012, when he acknowledged being the pharmacist in charge of a location where the two mistakes were made. According to the report, two children, aged 11 months and 2 years, were mistakenly dispensed a medicine containing morphine and other serious pain reliever medications, instead of the drug they were supposed to receive in order to treat acid reflux and related conditions. The Health Director stated that this pharmacist has now had three disciplinary proceedings since 1999, and that the similarity and severity of the two incidents “demonstrate an indifference to proper pharmaceutical practice.”

Young Girl Narrowly Survives Morphine Overmedication in Hospital

May 6, 2013 | Lebowitz & Mzhen

The U.S. Food and Drug Administration recently updated one of its website pages regarding medication error and consumer awareness. One of the stories included is a cautionary tale for all hospitalized individuals receiving medication intravenously.

When a 9 year old girl shattered her elbow on the soccer field, her M.D. parents took great care in selecting a hospital for her treatment. Following a successful three hour surgery to repair her injury, the girl was prescribed morphine through a pump, and was also hooked up to a heart rate monitor, breathing monitor, and blood oxygen monitor. She responded so well, that doctors decided to turn the morphine pump off, and discontinue regular vital sign checks.

The girl’s mother slept in her daughter’s hospital room that night. When she woke up in the midde of the night to check on her, the girl was barely breathing, and was verbally non-responsive. Apparently, the morphine pump was not only still turned on, but in fact had been turned up to high. The narcotic flooded the girl’s body, but thankfully she survived the ordeal. It is disturbing to consider what may have happened if the mother hadn’t woken up when she did.

The parents in this case were satisfied with the manner in which the hospital handled the error, which included acknowledging the error, addressing future treatment for their daughter, and a plan for how to avoid such errors in the future. The mother believes that short staffing and a holiday weekend may have been contributing factors.

Study Examines the Use of Antipsychotic Medications to Treat Children with ADHD

January 30, 2013 | Lebowitz & Mzhen

A study published last year examined the rate at which doctors prescribe antipsychotic medications for children diagnosed with attention deficit hyperactivity disorder, commonly known as ADHD or ADD. The researchers found a significant increase in the rate of prescriptions in recent years, and psychiatrists may now prescribe antipsychotics for children or adolescents with ADHD in one-third of all visits. The U.S. Food and Drug Administration (FDA) has not approved antipsychotic medications for ADHD in children, making it an “off-label” use. While this is not illegal per se, it raises concerns about known and unknown side effects and the risks of dangerous medication errors.

ADHD is a mental health condition that affects both children and adults, and can severely impact a child’s functioning in school and other activities. Symptoms include easy distraction, difficulty focusing, irritability, and difficulty remaining still. The most common pharmaceutical treatment for ADHD consists of stimulant drugs like Adderall and Ritalin. According to the Centers for Disease Control and Prevention (CDC), ADHD affects about 5.2 million children between the ages of three and seventeen, just over eight percent of all children in the U.S. in that age range. About twelve percent of boys and nearly five percent of girls in that age range have been diagnosed with ADHD.

National Patient Safety Board Would Reduce Medication Errors, Say Celebrity Supporters

June 7, 2012 | Lebowitz & Mzhen

The National Transportation Safety Board (NTSB), the federal agency that reviews highway and aviation accidents and makes recommendations for safety regulations, could serve as a model for an entity to monitor patient safety, according to a number of celebrities and other advocates. A medical journal article co-authored by actor Dennis Quaid and airline pilot Chesley B. “Sully” Sullenberg III argues for the creation of such an entity to apply lessons of previous medication errors and other mistakes towards the prevention of future problems. They cite the NTSB’s success at recommending effective revisions to airline safety regulations.

In an article published in the March 2012 issue of the Journal of Patient Safety, Quaid and Capt. Sullenberg join a medical doctor and an attorney in calling for creation of a safety board for patients. All four authors have experience as jet pilots, and all four have experience in aviation safety. Quaid additionally has endured a medical “near-death experience” with his twin children. They describe a “healthcare financing crisis” due in part to inefficient healthcare spending and waste, based on decisions made by corporate boards and administrators rather than doctors. They recommend adoption of “best practices” based on past experience, similar to the way the aviation industry has improved safety with the assistance of the NTSB.

Child Overdoses on Painkiller Due to Virginia Pharmacy Error

May 7, 2012 | Lebowitz & Mzhen

A child in Henrico County, Virginia suffered a serious overdose after a mixup of two drugs with similar names caused him to receive a powerful painkiller instead of his intended medication. The child reportedly recovered fully, but required hospitalization and gave his family and doctors quite a scare. Although there is no indication that the child’s family is pursuing legal action against the pharmacy, the pharmacist who filled the prescription received a reprimand from Virginia’s Board of Pharmacy.

On July 7, 2010, the child’s parents picked up his prescription at a local pharmacy. They thought that it was Methylin, which the child’s doctor had prescribed to treat attention deficit disorder (ADHD) with autistic tendencies. Methylin, also marketed as Ritalin or the generic methylphenidate, is a psychostimulant used to treat ADHD and other psychiatric conditions. Because the drug can be habit-forming, its use and distribution is tightly controlled. Furthermore, its effects vary greatly depending on the individual patient’s diagnosis, the size of the dosage, and the length of time it is taken. It requires the close monitoring of a doctor.

Two Families Sue Pharmacy, Alleging Their Children Received Incorrect Dosages

March 30, 2012 | Lebowitz & Mzhen

Two mothers are suing a pharmacy in Gig Harbor, Washington, claiming that their sons received incorrect dosages of prescription seizure medications. In both cases, the parents claim that the dosages dispensed by Olympic Pharmacy were big enough to be almost fatal for the children. The Washington state Board of Pharmacy has reportedly begun an investigation of the pharmacy based on the claims made in the lawsuits.

Laura Carlson says that Olympic dispensed the wrong dosage of medication for her son Chad twice in a period of about two years. In 2009, 11 year-old Chad received a prescription for 8 mls of Lorazepam, a powerful medication used to treat seizures and anxiety. The pharmacy allegedly dispensed the medication in a single pre-filled syringe. Chad reportedly became dizzy after taking the medication, eventually becoming unresponsive. He ended up hospitalized for four days while enduring hallucinations. Carlson looked at the packaging and saw that the prescription was for eight syringes, each containing a 1 ml. dose. Chad had significantly overdosed.

In 2011, Chad’s prescription had changed to pills rather than injections. Carlson filled a prescription at Olympic for 300 mg pills of Lorazepam. When Chad took them, he reportedly began vomiting repeatedly and violently. The pharmacy, it turned out, had given him 600 mg pills, doubling his dosage.

Kaeley Triller’s 3 year-old son reportedly had a similar experience in January. She says that Tristan Triller suffered insomnia, convulsions, and hallucinations after he took anti-seizure medication obtained at Olympic. Doctors at the ER determined that he had received four times the prescribed dose of medication. Once Tristan recovered, Triller did not consider the matter again until she learned of Chad Carlson’s two overdoses.

Both parents have filed lawsuits against Olympic, claiming the pharmacy negligently dispensed incorrect dosages of medications to their children at least three times in the past three years. Carlson’s suit reportedly claims that the pharmacy “poses an imminent public health danger” because of repeated medication errors and a lack of procedures and oversight to prevent future misfills.

Washington’s Board of Pharmacy also reportedly initiated an investigation of Olympic, based at least in part on the claims made by Carlson and Triller. The Board reportedly conducted fifty investigations of alleged pharmacy errors around the state in 2011. The Board has the authority to penalize licensed pharmacists, such as through fines or license suspensions, but it is limited to an administrative process. It cannot recover damages for the injured parties through litigation.

Pharmacy Mistakenly Gives Cancer Medication to Multiple Children

March 7, 2012 | Lebowitz & Mzhen

Children who should have received chewable fluoride tablets may instead have received Tamoxifen, a drug used to treat breast cancer, from a CVS Pharmacy in Chatham, New Jersey. Up to fifty families, according to initial reports, may have been affected by the error, in which the pharmacy dispensed the wrong medication over a period from December 1, 2011 to February 20, 2012. The fluoride pills, prescribed by dentists to prevent tooth decay, are typically flavored, while the cancer medication reportedly has a bad taste if chewed. Because of this, pharmacy representatives say that children would probably have noticed that they had received the wrong medication.

CVS issued a statement saying that children from roughly thirteen families mistakenly received Tamoxifen pills mixed in with the fluoride tablets. A spokesperson attributed the error to a “single medication restocking issue” at the one pharmacy location. The error affected the supply of 0.5mg fluoride tablets. The pharmacy reported that, according to the families they contacted, none of the children actually received any of the incorrect pills.

According to the Associated Press, Tamoxifen acts by blocking the female hormone estrogen. As such, it is not likely to cause serious harmful side effects to a child if taken for a short period of time. The New Jersey Attorney General’s office and the state’s Division of Consumer Affairs have nevertheless ordered the pharmacy to produce records for the period from December to February to account for the mixup. The pharmacy reports that it is still investigating the matter and is cooperating fully with state authorities.

The particular incident had a positive outcome because, fortunately, no one was injured, and the particular drug involved in the mixup had limited potential to cause harm. It underscores the critical importance, however, of remaining watchful for errors that can occur. In addition to checking to see that the label on the medication bottle matches the prescription, patients should also confirm that the medication itself matches the description. Many prescription bottles include a physical description of the medication itself, identifying the shape and color of the medication and stating whether it is in tablet, capsule, or another form. Not all pharmacies include this information on the bottle itself, but all prescriptions should include an insert with comprehensive information about the drug, including a physical description. This is a patient’s last line of defense against potential pharmacy errors.